Impact of Switching to Continuous Release Dopamine Agonists
Information source: University of Toledo Health Science Campus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson Disease
Intervention: Continuous Release Dopamine Agonists (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Toledo Health Science Campus Official(s) and/or principal investigator(s): Lawrence Elmer, MD, PhD, Principal Investigator, Affiliation: Medical University of Ohio
Summary
The purpose of this proposal is to determine if switching PD patients treated with
pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by
these patients. Side effects that we will monitor in particular include somnolence,
peripheral edema, cognitive decline with and without hallucinations. PD patients followed
in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at
least one of the following symptoms: somnolence, cognitive impairment with or without
hallucinations, or peripheral edema will be offered the opportunity to participate in this
study.
Clinical Details
Official title: The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Equal or improved motor scores as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), parts 3 (motor performance) and 4 (disability).A significant improvement in somnolence as measured by the Epworth Sleepiness Scale (ESS). A significant stabilization or improvement in the cognitive/mood battery of the Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9) and the Neuropsychiatric Inventory Questionnaire (NPI-Q). An improvement in peripheral edema, as measured by quantitative assessment of ankle and calf edema. Increased patient satisfaction/preference (Patient Satisfaction Questionnaire - PS) scores. Improvement in quality of life (Parkinson's Disease Questionnaire - PDQ-39).
Detailed description:
The purpose of this proposal is to determine if switching PD patients treated with
pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by
these patients. Side effects that we will monitor in particular include somnolence,
peripheral edema, cognitive decline with and without hallucinations. PD patients followed
in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at
least one of the following symptoms: somnolence, cognitive impairment with or without
hallucinations, or peripheral edema will be offered the opportunity to participate in this
study.
Fifteen subjects who are currently receiving pramipexole therapy (monotherapy or adjunctive
therapy) who are experiencing one or more of the following symptoms: somnolence, cognitive
decline with/without hallucinations, and peripheral edema will be asked if they are willing
to participate at the time of their clinic visit at the PDMDP.
The crossover from pramipexole to ropinirole CR will be performed over a 2 week interval.
During the first week, the initial drug dose will substitute ½ of the pramipexole with ½ of
the target dose of ropinirole CR. If subjects are tolerating the drug change, then 100% of
the target dose of ropinirole CR (and no pramipexole) will be started in the second week.
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Each subject must meet all of the following inclusion criteria to qualify for entrance
into the study:
- Subjects who are male or female and are aged 55 and older.
- Subjects and/or their legal guardians must be able and willing to give informed
consent.
- Subjects must be on stable doses of pramipexole for greater than 4 weeks duration
prior to screening.
- Subjects who are female must be non-pregnant and non-nursing. Women of Child-Bearing
Potential (WOCBP) must use a reliable method of contraception (e. g., oral
contraceptive or long-term injectable or implantable hormonal contraceptive,
double-barrier methods, such as condom and diaphragm, condom and foam, condom and
sponge or intra-uterine devices) and have a negative serum pregnancy test at
screening. Women are considered to not be of child-bearing potential if they have
been surgically sterilized (physician-documented hysterectomy or tubal ligation) or
if they are post-menopausal.
- Subjects must have a clinical diagnosis of Parkinson's based on the presence of at
least 2 of the 3 cardinal criteria - rest tremor, bradykinesia, rigidity - and no
obvious history of head trauma, stroke, infectious, structural, or metabolic
abnormality consistent with an alternative diagnosis to Parkinson's disease.
- Evidence of one or more of the following symptoms: somnolence (ESS score ≥ 9),
cognitive decline (MMSE < 24 ± presence of hallucinations (NPI-Q), peripheral edema
(present by objective physical exam with baseline ankle and calf circumference
measured in centimeters).
Exclusion Criteria:
A subject who meets any of the following criteria will NOT qualify for the study:
- Subjects must not be receiving any treatments for excess somnolence such as
amphetamine derivatives, other stimulants or Provigil.
- Subjects with actively treated malignancies, clinically significant heart disease,
kidney, liver, or pulmonary disorders will be excluded.
- Subjects with clinical depression who are not receiving stable doses of
antidepressant therapy in excess of 4 weeks duration.
- Subjects with history of orthostatic hypotension (>30mm drop in systolic pressure
and/or >20mm drop in diastolic pressure) associated with syncope.
- Subjects started within the last 14 days on any drug known to substantially inhibit
CYP1A2 (e. g., cimetidine, fluvoxamine) or induce CYP1A2 (e. g.omeprazole) (Note:
Subjects already on these agents may be enrolled but must remain on the stable doses
of the agents from 14 days prior to the beginning of the study).
- Subjects who have other medical conditions that are considered clinically unstable or
that may compromise the safety of the patient during this study.
Locations and Contacts
Medical University of Ohio, Toledo, Ohio 43614, United States
Additional Information
Starting date: January 2007
Last updated: March 18, 2009
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